A Blog of Members of the Administrative Law and Regulatory Practice Section of the American Bar Association

Friday, February 14, 2014

FDA Seeks Comment on Safety of Consumer Antiseptic Washes

by Elisabeth Ulmer

The FDA is inviting public comment
on the safety and effectiveness of “consumer
antiseptic products intended for use with water,” referred to as consumer
antiseptic washes.This proposed rule
seeks to update a 1994 rule (1994 TFM) that was published in the Federal
Register on June 17, 1994 (59 FR 31402) that classified “certain antiseptic
active ingredients” as safe.

The FDA now has two
objectives.First, it seeks to gather
additional information to support the safe nature of the active ingredients in
antiseptics.Second, it will require manufacturers
to prove that their consumer antiseptic washes are more clinically beneficial
than nonantibacterial soap and water.

This proposed rule distinguishes
between health care antiseptics and consumer antiseptic handwashes.The FDA planned to apply the same
effectiveness criteria to both consumer antiseptic and health care personnel
handwashes, but agrees with public comment that these two categories should be
handled separately because they serve different purposes.Thus, the current proposed rule covers only
consumer antiseptics, which include “antibacterial soaps, handwashes, and
antibacterial body washes,” but do not include hand sanitizers.

Because of new developments in
technology and new information about the amount and risks of systemic exposure
to these active ingredients, the active ingredients in antiseptic washes that
had been classified as safe should be reevaluated to comply with current safety
standards.Triclosan, a primary
ingredient, was found in a recent study to have a negative effect on muscle
function in mice and fish.Therefore,
the FDA invites “comment on what these findings tell us about triclosan's
potential impact on human health and the submission of additional data on this
subject.”The FDA is also concerned
about widespread antiseptic use impacting the development of bacterial
resistance.

Furthermore, a demonstration that
consumer antiseptic washes are more clinically beneficial than nonantibacterial
soap and water is necessary to balance the perceived risk of using these
washes.After the end of the 180-day
commenting period, manufacturers will have one year to submit their research.If they cannot prove that consumer antiseptic
washes are safe for human use and more beneficial as regular soap and water,
then the FDA will require them to change the advertising of these products or
to stop selling them.

Interested parties are invited to
submit comments about any aspect of this proposed rule by June 16, 2014, by any
of the following methods: